Clinical Trial Lead (m/w/d)

Salary

Core Qualifications

Preferred Qualifications

Key Responsibilities

• •Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies, with accountability for timelines, quality, and strategic oversight.
• •Serve as the primary contact for internal and external stakeholders regarding trial progress, governance, and issue resolution.
• •Author and manage essential trial documentation including protocols, informed consent forms (ICFs), study management plans, and integrated quality plans.
• •Provide strategic input and make scientific or medical decisions in early clinical development, in alignment with medical colleagues when applicable.
• •Ensure consistent use of study tools, training materials, and adherence to GCP/ICH guidelines, SOPs, and regulatory requirements.
• •Lead interdisciplinary core trial teams (e.g., data management, statistics, pharmacokinetics, clinical operations) and facilitate Trial Oversight Meetings.
• •Collaborate cross-functionally to support milestone achievement and proactively manage study risks and mitigation strategies.
• •Manage and mentor clinical operations staff, including performance appraisals, development planning, and resolution of employee relations issues.
• •Provide coaching on project planning, risk management, and problem-solving to ensure global alignment and adoption of process and technology tools.
• •Support staff in achieving project deliverables on time and within budget, ensuring quality and compliance with contractual obligations.
• •Monitor and guide financial aspects of trials including scope, budget, schedule, and change control.
• •Plan trial quality and risk monitoring/mitigation. Identify and address quality issues within studies, implementing corrective and preventive actions as needed.
• •Perform continuous review, risk identification, evaluation/analysis and communication on a trial level as applicable.
• •Train and support staff on clinical trial processes, systems, and competency frameworks to foster continuous development.
• •Consult with pharmacogenetics and safety experts on preclinical data, adverse events (SAEs, SUSARs), and side effect profiles as needed.
• •Demonstrate therapeutic area expertise (e.g., oncology, inflammatory, CMR) and apply clinical pharmacology knowledge to study design and execution.